Imagine spending years and hundreds of thousands of dollars on a formulation, only to have it compromised by counterfeiters or a data breach. This is not just a hypothetical scenario; it's a growing reality in today's pharmaceutical landscape. From counterfeit drugs infiltrating global markets to ransomware attacks crippling major manufacturers, the threats to pharmaceutical data integrity are very real. In this blog, we delve into these pressing challenges and explore best practices for safeguarding your valuable formulation data.
Threats to pharmaceutical data integrity
To understand how to best protect your data, you first have to understand the threats in today's market.
Counterfeit drugs
One of the most pressing threats to the pharmaceutical industry is counterfeit drugs. Bad actors can benefit greatly from recreating in-demand drugs with less or no active pharmaceutical ingredient (API). According to the World Health Organization:
And this issue isn't confined to developing countries; it's also infiltrating developed markets like the U.S., Canada, and Europe. Without the proper security measures in place, your formulation could be skimmed and stripped to create a counterfeit version. Not only does this undermine your ability to sell the real thing, but it can also seriously harm the patients you’re trying to serve.
Ransomware attacks
Ransomware is a type of software that blocks access to your data until a ransom is paid. In 2023, one of India’s largest drug producers, Sun Pharmaceutical Industries, was targeted by a ransomware group. As a result, their operations and revenue took a significant hit.
After all the time and money required to develop a formulation, it's no wonder the pharmaceutical industry is a top target for cybercriminals. They know your data is valuable. Even if you pay the ransom, however, there's no guarantee you'll get your data back. In 2024, 24% of companies that paid a ransom did not receive their data — another compelling reason to ensure your formulation is protected up front.
Data integrity compliance violations
Apart from actually developing a formulation, documenting your process is key to getting FDA approval. Even if it's an accident, the loss or corruption of data could result in delays and/or fines from the FDA. When reviewing your application, the FDA looks for:
- Missing or manipulated data
- Uncontrolled documentation
- Failure to document work in real-time
- Aborted or invalidated results without justification
Severe weather, human error, or faulty technology could all lead to gaps in your formulation data. For that reason, it's crucial to have security measures in place to mitigate all three variables.
Best practices for ensuring formulation security
Protecting your formulation data is not just a digital effort. It requires a 360° approach with both online and offline tactics. By implementing these protection measures, pharmaceutical companies can significantly enhance the security of their formulation data, protecting their intellectual property and maintaining compliance with industry regulations.
Digital security
Redundant data
According to a 2024 trend report, 96% of ransomware attacks targeted backup sources. It's not enough to rely on one — or even two — records of data. When evaluating potential CDMO partners, ask where and how they back up their documentation.
Cybersecurity software
Robust firewalls and intrusion detection systems are essential for identifying and blocking threats before they can access your data. Together, these tools significantly reduce the risk of data breaches and ensure that even if data is intercepted, it remains unreadable without proper decryption keys.
Ongoing monitoring and audits
Just as with formulation, security can't function on a "set-it-and-forget-it" system. Continuous monitoring helps protect data by identifying new vulnerabilities and necessary updates.
Physical security
Power continuity
Power outages not only disrupt operations but they can put your formulation data at risk. Battery and generator backups ensure all systems, including critical equipment and security, remain operational.
Operational contingencies
Redundant systems ensure zero downtime for essential processes, while an on-site inventory of critical spare parts minimize disruptions that could compromise data or product integrity.
Accessed control
Never underestimate the importance of keycard access. Combined with detailed logs, this limits unauthorized entry and potential data theft. Additionally, comprehensive Non-Disclosure Agreements (NDAs) signed by all staff and contractors provide legal protection and reinforce the importance of data security among personnel.
Choosing a secure CDMO
While you may be protective of your formulation, your CDMO partner is ultimately responsible for safeguarding your data during development and manufacturing. When selecting a CDMO to work with, ensure they follow all security best practices. To help get a good idea of their capabilities, consider their:
- Reputation: Look for CDMOs with a proven history of maintaining data integrity.
- Industry Experience: Choose a partner familiar with your specific pharmaceutical niche.
- Security Protocols: Ensure they have robust security measures in place.
- Compliance History: Check their record of compliance with regulatory bodies.
Partner with American Injectables
As if developing a novel drug isn't hard enough, you have to ask "Is my data safe?". Between counterfeit drugs, ransomware attacks, and human error, the pharmaceutical industry is not short on threats. But by partnering with a secure CDMO, you can help ensure your investment is protected.
At American Injectables, we know that CDMOs talk a lot about quality. We let our track record do the talking. As an end-to-end partner, we can help see your formulation from concept to reality. Explore how we've designed our facilities and processes with security at the center.
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